3D Visualized Left Atrial Appendage Occlusion Device

Abstract

The present invention relates to the field of medical equipment technology, and in particular to a three-dimensional visual left atrial appendage occlusion device, comprising: a left atrial appendage occluder, a joint component, a pushing component and a three-dimensional marking system. The front end of the pushing component is connected to the left atrial appendage occluder, and the pushing component is used to store the left atrial appendage occluder to its inner side or release it from the inner side. A plurality of first electrodes are arranged on the outside of the left atrial appendage occluder, and the first electrodes are electrically connected to the three-dimensional marking system; a plurality of second electrodes are arranged on the front end of the pushing component, and the second electrodes are electrically connected to the three-dimensional marking system. The three-dimensional visual left atrial appendage occlusion device provided by the present invention ensures the coaxiality of the occluder and the left atrial appendage, and improves the effectiveness of the occluder insertion.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a three-dimensional visible left atrial appendage occlusion device. Background Art

[0002] At present, most of the surgeries performed in vivo at home and abroad are conducted under the guidance of X-ray fluoroscopy. For example, the mainstream atrial septum puncture is a two-dimensional plane perspective technology developed more than half a century ago. X-rays cannot directly determine the specific location, and lack accurate hints on the three-dimensional structure. Mastering this technology requires a long period of clinical accumulation. If the patient has a heart mutation, it is extremely difficult to puncture. When the patient is too obese and the X-ray machine has low clarity, it will further affect the success rate and safety of the puncture. The atrial septum puncture under the guidance of intracardiac ultrasound advocated by foreign countries, especially the United States, is to add an intracardiac ultrasound catheter on the basis of X-ray fluoroscopy. Although it increases the accuracy of positioning, it is generally based on two-dimensional plane technology, which is difficult to well reflect the real three-dimensional space of the heart. At present, it is difficult to achieve accurate positioning in left atrial appendage closure surgery. Summary of the invention

[0003] The present invention aims to solve the technical problem that it is difficult to achieve accurate positioning in left atrial appendage occlusion surgery in the prior art, and provides a three-dimensional visual left atrial appendage occlusion device.

[0004] The technical solution of the present invention to solve the above technical problems is as follows:

[0005] A three-dimensional visual left atrial appendage occlusion device, comprising: a left atrial appendage occluder, a joint component, a pushing component and a three-dimensional marking system;

[0006] The front end of the pushing component is connected to the left atrial appendage occluder, and the pushing component is used to store the left atrial appendage occluder inside or release it from the inside;

[0007] A plurality of first electrodes are arranged outside the left atrial appendage occluder, and the first electrodes are electrically connected to the three-dimensional marking system; a plurality of second electrodes are arranged at the front end of the pushing component, and the second electrodes are electrically connected to the three-dimensional marking system.

[0008] Further, the left atrial appendage occluder comprises: a cage structure made of memory material; the first electrode comprises: a distal electrode, a proximal electrode, a shoulder electrode and a waist electrode;

[0009] The distal electrode is connected to one end of the cage-like structure, and the proximal electrode is connected to the other end of the cage-like structure; the shoulder of the cage-like structure is connected to a plurality of shoulder electrodes; the waist of the cage-like structure is connected to a plurality of waist electrodes; the distal electrode, the proximal electrode, the shoulder electrode and the waist electrode are electrically connected to the joint component respectively; the joint component is electrically connected to the three-dimensional mark side system.

[0010] Furthermore, a flow-blocking membrane is arranged on the outside of the waist and the bottom of the cage-like structure; and a plurality of barbs are arranged on the outside of the shoulder and the top of the cage-like structure.

[0011] Furthermore, the connector components include: a transmission connector, an electrical signal connector and a pull-out terminal;

[0012] A plurality of plugs are provided at the lower end of the transmission joint, and the front ends of the plugs are electrically connected to the first electrodes on the cage-like structure one by one; a threaded hole is provided at the lower end of the transmission structure and located inside the plurality of plugs;

[0013] The front end of the electrical signal connector is provided with a jack corresponding to the plug one by one; the inner side of the jack is provided with a U-shaped hole penetrating the electrical signal connector; the front end of the pushing component passes through the U-shaped hole and is screwed and fixed to the threaded hole; the jack is electrically connected to the three-dimensional marking system through wires;

[0014] The pull-out end is connected to the front end of the pushing component, and the pull-out end is arranged on the inner side of the U-shaped groove.

[0015] Furthermore, the pushing component includes: a pushing tube and a catheter sheath; the second electrode is a ring electrode;

[0016] The front end of the push tube is provided with a plurality of the annular electrodes; the push tube is arranged inside the catheter sheath, and the push tube can move forward and backward along the catheter sheath;

[0017] The front end of the push tube passes through the U-shaped hole and is screwed and fixed to the threaded hole; the pull-out end is connected to the front end of the push tube.

[0018] Furthermore, it also includes: a hand-held adjustment part; the hand-held adjustment part is connected to the rear end of the pushing component.

[0019] Furthermore, the handheld adjustment part includes: a handle, a pull-out button and a knob;

[0020] The rear end of the push tube is inserted into the inner side of the handle; the knob is arranged on the handle, and the knob is connected to the push tube;

[0021] The handle is provided with a mounting groove which runs through the inside and outside, the pull-out button is arranged in the mounting groove, and the pull-out button is connected with the push tube.

[0022] The three-dimensional visual left atrial appendage occlusion device provided by the present invention has at least the following beneficial effects or advantages:

[0023] The three-dimensional visual left atrial appendage occlusion device provided by the embodiment of the present invention has a front end of a push component connected to a left atrial appendage occluder, and the push component is used to store the left atrial appendage occluder inside or release it from the inside; a plurality of first electrodes are arranged outside the left atrial appendage occluder, and the first electrodes are electrically connected to the three-dimensional marking system; a plurality of second electrodes are arranged at the front end of the push component, and the second electrodes are electrically connected to the three-dimensional marking system. The three-dimensional visual left atrial appendage occlusion device provided by the embodiment of the present invention has a head end of an electro-positioning catheter sheath including at least two electrodes, which can observe the position of the catheter in the heart, and facilitate the determination of the insertion position of the occluder and the push tube. A plurality of electrodes are arranged on the occluder, and each of them is numbered. In the three-dimensional mapping system, different parts of the occluder are found according to points with different numbers, forming the three-dimensional shape of the occluder, which can be directly seen in the three-dimensional interface, and according to its image, the appropriate position of the left atrial appendage is observed and determined and the occluder is inserted, which ensures the coaxiality of the occluder and the left atrial appendage and improves the effectiveness of the insertion of the occluder. In addition, the three-dimensional visual left atrial appendage occlusion device provided by the embodiment of the present invention has a single inner plug structure, which avoids the hidden danger of the outer sealing disc easily falling off, and improves its safety. The insertion operation of the occlusion head can be performed without X-ray, which is safer. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 A schematic diagram of the structure of a three-dimensional visual left atrial appendage occlusion device provided in an embodiment of the present invention;

[0025] Figure 2 A schematic diagram of the catheter sheath structure provided by an embodiment of the present invention;

[0026] Figure 3 A schematic diagram of the structure of a left atrial appendage occluder provided in an embodiment of the present invention;

[0027] Figure 4 A schematic diagram of the structure of a joint component provided by an embodiment of the present invention;

[0028] Figure 5 A schematic diagram of the structure of a push component provided in an embodiment of the present invention.

[0029] In the accompanying drawings, the components represented by the reference numerals are listed as follows:

[0030] 1-left atrial appendage occluder, 11-cage structure, 12-distal electrode, 13-proximal electrode, 14-barb, 2-connector component, 21-transmission connector, 22-electrical signal connector, 23-pull-out terminal, 3-push component, 31-catheter sheath, 32-push tube, 33-ring electrode, 4-three-dimensional marking system, 5-handheld adjustment part, 51-handle, 52-knob, 53-pull-out button. DETAILED DESCRIPTION

[0031] The present invention aims to solve the technical problem that it is difficult to achieve accurate positioning in left atrial appendage occlusion surgery in the prior art, and provides a three-dimensional visual left atrial appendage occlusion device.

[0032] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] The embodiment of the present invention provides a three-dimensional visual left atrial appendage occlusion device, see Figure 1-Figure 5 , which mainly includes: a left atrial appendage occluder 1, a joint component 2, a pushing component 3 and a three-dimensional marking system 4. The front end of the pushing component 3 is connected to the left atrial appendage occluder 1, and the pushing component is used to store the left atrial appendage occluder 1 inside or release it from the inside. A plurality of first electrodes are arranged outside the left atrial appendage occluder 1, and the first electrodes are electrically connected to the three-dimensional marking system 4, which are used to display the unfolded shape and position of the left atrial appendage occluder 1 in the body; a plurality of second electrodes are arranged at the front end of the pushing component 3, and the second electrodes are electrically connected to the three-dimensional marking system 4, which are used to display the position of the pushing component 3 in the body.

[0034] Wherein, the left atrial appendage occluder 1 comprises: a cage structure 11 made of memory material (such as nickel titanium wire), which is shrinkable and expandable, and has the same shape after each expansion due to its memory function. The first electrode comprises: a distal electrode 12, a proximal electrode 13, a shoulder electrode and a waist electrode. The distal electrode 12 is connected to one end of the cage structure 11, and the proximal electrode 13 is connected to the other end of the cage structure 11, and the distal electrode 12 and the proximal electrode 13 are arranged opposite to each other. The shoulder of the cage-like structure 11 is connected to a plurality of shoulder electrodes (four shoulder electrodes are symmetrically arranged in this embodiment); the waist of the cage-like structure 11 is connected to a plurality of waist electrodes (four waist electrodes are symmetrically arranged in this embodiment); the distal electrode 12, the proximal electrode 13, the shoulder electrode and the waist electrode are electrically connected to the joint component 2 respectively; specifically, the distal electrode 12, the proximal electrode 13, the shoulder electrode and the waist electrode are electrically connected to the joint component 2 respectively through thin wires, and the thin wires are fixed together with the nickel-titanium wires constituting the plugging head, and each thin wire is connected to a signal transmission connector 21 at the proximal end of the plugging head along different nickel-titanium wires, and is connected to the outside along the delivery sheath. Then at least ten electrodes are arranged in the electro-positioning left atrial appendage occluder 1, and then the plugging head structure is composed of at least ten nickel-titanium wires. The joint component 2 is electrically connected to the three-dimensional marking system 4. The waist and bottom outer side of the cage-like structure 11 are provided with a flow-blocking membrane, and only a part of the main body of the left atrial appendage occluder 1 (i.e., the part without the flow-blocking membrane) is placed in the left atrial appendage, and directly cooperates with the left atrial appendage, so that it is easy to find the left atrial appendage axis, and as long as the coaxiality of the two is ensured, the effectiveness of the occlusion can be guaranteed. A plurality of barbs 14 are provided on the shoulder and the outer side of the top of the cage-like structure 11.

[0035] See also Figure 1 and Figure 4 , the connector component 2 includes: a transmission connector 21, an electrical signal connector 22 and a pull-out terminal 23. A plurality of plugs are arranged at the lower end of the transmission connector 21, and the front ends of the plugs are electrically connected to the first electrode on the cage structure 11 one by one; a threaded hole is arranged at the lower end of the transmission structure and located on the inner side of the plurality of plugs. A jack corresponding to the plug is arranged at the front end of the electrical signal connector 22; a U-shaped hole penetrating the electrical signal connector 22 is arranged on the inner side of the jack; the front end of the pushing component 3 passes through the U-shaped hole and is screwed and fixed to the threaded hole; the jack is electrically connected to the three-dimensional marking side system 4 through wires. The pull-out terminal 23 is connected to the front end of the pushing component 3, and the pull-out terminal 23 is arranged on the inner side of the U-shaped groove.

[0036] See also Figure 1 and Figure 2The push component 3 includes: a push tube 32 and a catheter sheath 31; the second electrode is an annular electrode 33. A plurality of annular electrodes 33 (two in this embodiment) are arranged at the front end of the push tube 32; the push tube 32 is arranged inside the catheter sheath 31, and the push tube 32 can move forward and backward along the catheter sheath 31. The front end of the push tube 32 passes through the U-shaped hole and is screwed and fixed with the threaded hole; the pull-out end 23 is connected to the front end of the push tube 32. The catheter sheath 31 is arranged as an inner and outer layer, and the thin wire is arranged in the gap between the two layers of the catheter sheath 31, and the routing form of the thin wire is winding or linear.

[0037] In a preferred embodiment provided by the present invention, see Figure 1 , and also includes: a hand-held adjustment part 5; the hand-held adjustment part 5 is connected to the rear end of the pushing part 3. Specifically, the hand-held adjustment part 5 includes: a handle 51, a pull-out button 53 and a knob 52. The rear end of the pushing tube 32 is inserted into the inner side of the handle 51; the knob 52 is arranged on the handle 51, and the knob 52 is connected to the pushing tube 32, and the pushing tube 32 can be rotated by rotating the knob 52. The handle 51 is provided with an installation groove that runs through the inside and outside, and the pull-out button 53 is arranged in the installation groove, and the pull-out button 53 is connected to the pushing tube 32. The electrical signal connector 22 can be inserted or pulled out by pulling the pull-out button 53 back and forth.

[0038] See also Figure 1-Figure 5 The working process of the three-dimensional visual left atrial appendage occlusion device provided by the embodiment of the present invention is as follows:

[0039] During the operation, firstly, a guide wire is inserted along the right femoral vein; then the electrical signal connector 22 is connected to the three-dimensional mapping system, and the catheter sheath 31 is inserted into the right femoral vein along the guide wire. During the process of the catheter sheath 31 entering the right femoral vein along the guide wire, the catheter sheath 31 can observe the position of the annular electrode in the catheter sheath 31 through the three-dimensional mapping system, that is, the position of the front end of the electrically positioned catheter sheath 31. When the catheter sheath 31 enters the right atrium, the head end of the catheter sheath 31 is adjusted to a suitable position in combination with the right atrium structure; then a visualized puncture device is inserted along the catheter sheath 31, the puncture device is withdrawn, and the above-mentioned process of pushing the guide wire and inserting the catheter sheath 31 is repeated, so that the catheter sheath 31 enters the left atrium. Specifically, after the catheter sheath 31 enters the left atrium, the three-dimensional structure of the left atrium and left atrial appendage reconstructed in the three-dimensional mapping system is used to adjust the position of the front end of the electrically positioned catheter sheath 31, so that the electrically positioned catheter sheath 31 accurately enters the left atrial appendage. After the catheter sheath 31 enters the left atrial appendage, the three-dimensional mapping system connector led out from the tail end of the handheld adjustment part 5 is connected to the three-dimensional mapping system, and then the push tube 32 and the occluding head folded in the catheter sheath 31 are sent into the left atrial appendage along the catheter sheath 31. In the three-dimensional mapping system, the appropriate position of the catheter sheath 31 head end at the entrance of the left atrial appendage is adjusted, the push tube 32 is pushed out, and the left atrial appendage occluder 1 is released. The multiple electrodes thereon generate different potentials. The position of each electrode is observed in the three-dimensional system. With the help of three-dimensional visualization, the position of the occluder in the left atrial appendage is adjusted so that the occluder is coaxial with the left atrial appendage, and the occluder barb 14 is anchored on the inner wall of the left atrial appendage. Finally, loosen the threaded connection between the push tube 32 and the occluder transmission connector 21, pull back the push tube 32, and when the pull-out end 23 on the push tube 32 hits the step of the electrical signal connector 22, continue to pull the push tube 32 outward, the coupling connector will be disconnected, and the electrical signal connector 22 will be withdrawn along with the push tube 32, and then withdraw from the delivery device and the catheter guide wire in turn.

[0040] The three-dimensional visual left atrial appendage occlusion device provided by the present invention has at least the following beneficial effects or advantages:

[0041] The three-dimensional visual left atrial appendage occlusion device provided by the embodiment of the present invention has a front end of a push component connected to a left atrial appendage occluder, and the push component is used to store the left atrial appendage occluder inside or release it from the inside; a plurality of first electrodes are arranged outside the left atrial appendage occluder, and the first electrodes are electrically connected to the three-dimensional marking system; a plurality of second electrodes are arranged at the front end of the push component, and the second electrodes are electrically connected to the three-dimensional marking system. The three-dimensional visual left atrial appendage occlusion device provided by the embodiment of the present invention has a head end of an electro-positioning catheter sheath including at least two electrodes, which can observe the position of the catheter in the heart, and facilitate the determination of the insertion position of the occluder and the push tube. A plurality of electrodes are arranged on the occluder, and each of them is numbered. In the three-dimensional mapping system, different parts of the occluder are found according to points with different numbers, forming the three-dimensional shape of the occluder, which can be directly seen in the three-dimensional interface, and according to its image, the appropriate position of the left atrial appendage is observed and determined and the occluder is inserted, which ensures the coaxiality of the occluder and the left atrial appendage and improves the effectiveness of the insertion of the occluder. In addition, the three-dimensional visual left atrial appendage occlusion device provided by the embodiment of the present invention has a single inner plug structure, which avoids the hidden danger of the outer sealing disc easily falling off, and improves its safety. The insertion operation of the occlusion head can be performed without X-ray, which is safer.

[0042] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A three-dimensional visual left atrial appendage occlusion device, characterized in that: include: Left atrial appendage occluder, connector components, push components, three-dimensional mapping system and handheld adjustment unit; The front end of the pushing component is connected to the left atrial appendage occluder, and the pushing component is used to store the left atrial appendage occluder inside or release it from the inside; A plurality of first electrodes are arranged outside the left atrial appendage occluder, and the first electrodes are electrically connected to the three-dimensional mapping system; a plurality of second electrodes are arranged at the front end of the pushing component, and the second electrodes are electrically connected to the three-dimensional mapping system; The left atrial appendage occluder comprises: a cage-shaped structure made of memory material; the first electrode comprises: a distal electrode, a proximal electrode, a shoulder electrode and a waist electrode; The distal electrode is connected to one end of the cage-like structure, and the proximal electrode is connected to the other end of the cage-like structure; the shoulder of the cage-like structure is connected to a plurality of shoulder electrodes; the waist of the cage-like structure is connected to a plurality of waist electrodes; the distal electrode, the proximal electrode, the shoulder electrode and the waist electrode are electrically connected to the joint component respectively; the joint component is electrically connected to the three-dimensional mapping system; The connector components include: a transmission connector, an electrical signal connector and a pull-out terminal; A plurality of plugs are provided at the lower end of the transmission connector, and the front ends of the plugs are electrically connected to the first electrodes on the cage-like structure one by one; a threaded hole is provided at the lower end of the transmission connector and located inside the plurality of plugs; The front end of the electrical signal connector is provided with a jack corresponding to the plug one by one; the inner side of the jack is provided with a U-shaped hole penetrating the electrical signal connector; the front end of the pushing component passes through the U-shaped hole and is screwed and fixed to the threaded hole; the jack is electrically connected to the three-dimensional mapping system through wires; The pull-out end is connected to the front end of the pushing component, and the pull-out end is arranged inside the U-shaped hole; The hand-held adjustment part is connected to the rear end of the pushing component; the hand-held adjustment part comprises: a handle, a pull-out button and a knob; the electrical signal connector can be inserted or pulled out by pulling the pull-out button forward and backward.

2. The three-dimensional visual left atrial appendage occlusion device according to claim 1, characterized in that: The waist and the outer side of the bottom of the cage-like structure are provided with a flow-blocking film; the shoulder and the outer side of the top of the cage-like structure are provided with a plurality of barbs.

3. The three-dimensional visual left atrial appendage occlusion device according to claim 2, characterized in that: The pushing component includes: a pushing tube and a catheter sheath; the second electrode is a ring electrode; The front end of the push tube is provided with a plurality of the annular electrodes; the push tube is arranged inside the catheter sheath, and the push tube can move forward and backward along the catheter sheath; The front end of the push tube passes through the U-shaped hole and is screwed and fixed to the threaded hole; the pull-out end is connected to the front end of the push tube.

4. The three-dimensional visual left atrial appendage occlusion device according to claim 3, characterized in that: The rear end of the push tube is inserted into the inner side of the handle; the knob is arranged on the handle, and the knob is connected to the push tube; The handle is provided with a mounting groove which runs through the inside and outside, the pull-out button is arranged in the mounting groove, and the pull-out button is connected with the push tube.

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